Botulism Toxin Injection as a Treatment for Arthritis of the Basal Thumb Joint

This study has suspended participant recruitment.
(Additional funding needed to continue this study.)
Sponsor:
Information provided by (Responsible Party):
Stephen Colbert, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01045694
First received: January 7, 2010
Last updated: February 8, 2014
Last verified: February 2014
  Purpose

Basal arthritis of the thumb is a common condition with increased prevalence in post-menopausal women, obese persons, and the elderly. Surgical options are varied and efficacious, but not all patients are candidates for surgery. The successes and pitfalls of previous, similar trials are carefully considered in the creation of our own. Though steroid injection is the standard of care in basal joint arthritis, current data does not support its efficacy beyond placebo effect. No trial has yet examined the efficacy of botulinum toxin type A (BTX-A) injection into the basal thumb joint nor compared it to steroid. Since efficacy of steroid is questionable at best, our hope is that BTX-A injection of the basal joint might be the next great tool in treating this common, debilitating disease.


Condition Intervention Phase
Basilar Joint Arthritis
Basal Thumb Joint Arthritis
Trapeziometacarpal Arthritis
Carpometacarpal Arthritis
Drug: Botulinum Toxin Type A
Drug: Steroid - Triamcinolone Acetonide
Drug: Lidocaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Botulinum Toxin Versus Steroid Injection for Basal Joint Arthritis of the Thumb: a Randomized, Double Blind, Placebo-controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Pain [ Time Frame: twenty-four hours, ten days, twelve weeks, six months, and one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Range of motion [ Time Frame: twelve weeks, six months, and one year ] [ Designated as safety issue: No ]
  • Strength [ Time Frame: twelve weeks, six months, and one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botulinum Toxin Type A
Arm investigates the efficacy of Botulinum Toxin A injection for the treatment of basal thumb joint arthritis
Drug: Botulinum Toxin Type A
One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule
Other Names:
  • Botox Cosmetic
  • Botox
Active Comparator: Steroid - Triamcinolone Acetonide
Arm uses the standard of care - Steroid injection - as an active comparator to the experimental injection of Botulinum Toxin A for the treatment of basal thumb joint arthritis
Drug: Steroid - Triamcinolone Acetonide
Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution
Other Name: Kenalog-40
Placebo Comparator: Lidocaine
Arm uses plain lidocaine injection to serve as a baseline for evaluating the efficacy of Botulinum toxin as compared to steroid injection for the treatment of basal thumb joint arthritis.
Drug: Lidocaine
Single injection of 1 - 3 mL of 2% Lidocaine
Other Name: Xylocaine

Detailed Description:

Purpose: Basal joint arthritis, or carpometacarpal (CMC) osteoarthritis, of the thumb is very common, particularly in the elderly. Morbidities include pain, decreased range of motion, and decreased strength. Nonsurgical treatments for CMC arthritis include oral analgesics, splinting, and steroid injection. In multiple recent trials, botulinum toxin A (BTX-A) injection has been shown to be an efficacious nonsurgical option for osteoarthritis of large joints, including those that have failed steroid injections. To our knowledge, the efficacy of BTX-A injection in thumb CMC arthritis has not been examined.

Methods: Patients with a clinical and radiographic diagnosis of basal joint arthritis who are appropriate and willing candidates for injection therapy will be selected. The primary symptom indicating need for injection would be pain not controlled with more conservative measures (e.g. nonsteroidal anti-inflammatory drugs (NSAIDs), splinting, physical therapy, etc.) Weakness and impaired functioning are also considered. Exclusion criteria will include any injection within the last 12 months or surgical treatment. All patients will undergo Eaton staging radiographically prior to treatment. Informed consent will be obtained and patients will be randomly assigned to one of three groups. One group will receive BTX-A injections, the second group will receive triamcinolone plus lidocaine injections, and the third group will receive saline plus lidocaine injections of the thumb CMC joint. Prior to treatment, patients' baseline function will be assessed with pinch, grip, and range of motion measurements, and the affect of their disease will be measured with a visual analog pain scale and the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. Pain scales and DASH questionnaires will be completed at twenty-four hours, ten days, twelve weeks, six months, and one year after treatment. Pain scales will be recorded for average pain and maximum pain. Clinical evaluations with pinch, grip, and range of motion measurements will occur ten days, twelve weeks, six months, and one year after treatment. All patients will be asked to return when sufficient symptoms recur to warrant further treatment.

Expected Results: We hypothesize that BTX-A injection will have equal or better efficacy than steroid injection for the treatment of basal joint arthritis.

Expected Conclusion: No study to date has examined BTX-A as a treatment for basal joint arthritis. Some patients are not surgical candidates and are reliant on non-surgical treatments for pain control and maintenance of function. BTX-A has shown to be effective in treating osteoarthritis of larger joints that undergo frequent use, including cases resistant to steroid injections. The basal thumb joint also undergoes frequent use and is often resistant to steroid injection. We believe that BTX-A will provide another efficacious non-surgical option for treatment of the CMC joint of the thumb. We estimate that the study will require approximately three to four years to achieve adequate patient numbers for each group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Radiographic evidence of basal joint arthritis
  • Associated symptoms of basal joint arthritis including:
  • Pain
  • Decreased range of motion
  • Decreased thumb strength

Exclusion Criteria:

  • Persons under the age of 18
  • Women who are currently pregnant
  • Incompetent persons or persons otherwise incapable of effectively communicating the subjective experience of pain
  • Prior surgery on the joint
  • Injection in the last 12 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045694

Locations
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Stephen H. Colbert, MD University of Missouri-Department of Surgery-Division of Plastic Surgery
  More Information

No publications provided

Responsible Party: Stephen Colbert, Assistant Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01045694     History of Changes
Other Study ID Numbers: 1146517
Study First Received: January 7, 2010
Last Updated: February 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
Carpometacarpal Joints
Osteoarthritis

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases
Botulinum Toxins, Type A
Lidocaine
Botulinum Toxins
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on August 18, 2014